Opportunity Information: Apply for RFA DA 21 031
The funding opportunity titled "Digital Technologies to Address the Social Determinants of Health in Context of Substance Use Disorders (SUD) (R41/R42 Clinical Trial Optional)" (Funding Opportunity Number RFA-DA-21-031) is a National Institutes of Health (NIH) small business grant initiative designed to accelerate the development of practical, commercial-ready digital health products that can reduce substance use risk and improve outcomes by addressing social determinants of health. Rather than focusing only on the biological or clinical aspects of addiction, this announcement centers on the real-world social and environmental conditions that shape vulnerability to drug use and recovery trajectories, including but not limited to opioid-related harms. The overall goal is to support research and development efforts that translate into scalable tools that can be deployed in communities, health systems, and support settings where people affected by substance use disorders live and seek help.
This announcement uses the SBIR phased mechanism (R41/R42), which is specifically aimed at small businesses developing technologies with a clear path toward commercialization. In practice, Phase I (R41) generally supports early-stage feasibility, proof-of-concept, prototype development, and initial testing, while Phase II (R42) supports more advanced research and development, refinement, and stronger evidence-building toward real-world use and market readiness. The phrase "Clinical Trial Optional" signals that applicants may propose projects that include a clinical trial, but they are not required to do so. That flexibility allows companies to pursue a range of evidence-generation approaches, from user-centered design and feasibility pilots to larger effectiveness studies, depending on the maturity of the product and the scientific questions being addressed.
The key emphasis is on digital technologies that can positively influence social determinants of health in the context of substance use disorders. Social determinants of health typically include factors like housing stability, employment and income, education, access to transportation, food security, exposure to violence, social support, discrimination, and access to health and social services. Under this opportunity, the digital product should not merely track these factors, but aim to measurably improve them or reduce their negative impacts in ways that are relevant to substance use prevention, treatment engagement, harm reduction, relapse prevention, or long-term recovery. That could mean building tools that help people navigate services, connect with community resources, coordinate care, improve communication and trust between patients and providers, reduce barriers to attending treatment, or strengthen protective social connections. The announcement is oriented toward interventions that address upstream drivers of risk, recognizing that unstable living conditions, limited access to resources, and structural barriers can directly affect drug use patterns and the ability to start and sustain recovery.
Because the opportunity is focused on commercializable products, applications are expected to reflect a product-development mindset alongside scientific rigor. Competitive proposals typically articulate a clear unmet need, define the intended users and use settings, describe the digital solution in concrete terms, and outline a development plan that includes usability, implementation considerations, and an evidence strategy appropriate for the stage of the technology. While the source text does not list specific technical requirements, the "digital health-based products" framing generally encompasses software and mobile applications, telehealth or remote support platforms, digital screening and referral tools, digital therapeutics, and other technology-enabled service models that can be integrated into real-world workflows. The commercialization focus also implies that applicants should be thinking about adoption pathways, potential customers or purchasers (such as providers, payers, public health entities, or employers), regulatory and privacy considerations when applicable, and how the product could be sustained beyond the grant period.
Eligibility is limited to small businesses, consistent with NIH SBIR requirements. Importantly, non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, the announcement notes that "foreign components" may be allowed as defined by the NIH Grants Policy Statement. In NIH terms, that typically means a U.S.-based applicant organization may, under certain circumstances and with appropriate justification and approvals, include a discrete portion of the project to be performed outside the United States when it offers a unique resource or expertise not readily available domestically. Even when allowed, such foreign components are not the same as a foreign applicant, and they must align with NIH policy and be well-justified as necessary for the project.
Administratively, this is a discretionary grant opportunity under NIH, associated with CFDA number 93.279. The opportunity was created on December 22, 2020, and the original closing date listed is February 26, 2021. The provided source excerpt does not specify an award ceiling or the number of expected awards, which means those details would normally be confirmed in the full announcement on NIH/Grants.gov or the NIH Guide notice. The administering agency is the National Institutes of Health, and given the RFA-DA prefix, it is associated with NIH's drug abuse portfolio, aligning with the focus on populations affected by the use of drugs including opioids.
In short, this grant is aimed at U.S. small businesses building digital tools that do more than provide clinical content; they are expected to confront the social and environmental realities that drive substance use risk and complicate recovery. The NIH is effectively signaling that meaningful progress on substance use disorders requires solutions that can operate in everyday contexts, reduce structural barriers, and connect people to resources and supports, and that digital technologies are a promising way to deliver those improvements at scale with a viable commercialization pathway.Apply for RFA DA 21 031
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Digital Technologies to Address the Social Determinants of Health in Context of Substance Use Disorders (SUD) (R41/R42 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
- This funding opportunity was created on 2020-12-22.
- Applicants must submit their applications by 2021-02-26. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The funding opportunity is titled "Digital Technologies to Address the Social Determinants of Health in Context of Substance Use Disorders (SUD) (R41/R42 Clinical Trial Optional)" and the Funding Opportunity Number is RFA-DA-21-031.
Which agency is offering this funding opportunity?
The administering agency is the National Institutes of Health (NIH). Based on the RFA-DA prefix, it aligns with NIH's drug abuse portfolio.
What type of program is this (SBIR, STTR, etc.)?
This is an NIH Small Business Innovation Research (SBIR) opportunity using the phased mechanism R41/R42.
What is the overall purpose of this funding opportunity?
The purpose is to accelerate development of practical, commercial-ready digital health products that reduce substance use risk and improve outcomes by addressing social determinants of health in the context of substance use disorders (SUD), including (but not limited to) opioid-related harms.
What does it mean that the project focuses on social determinants of health (SDOH) rather than only clinical or biological factors?
It means the work should target real-world social and environmental conditions that shape vulnerability to drug use and recovery trajectories. The emphasis is on upstream drivers of risk and barriers to recovery that occur in everyday life and systems of care, not only on clinical treatment content or biological mechanisms.
What are examples of social determinants of health relevant to this opportunity?
Examples mentioned include housing stability, employment and income, education, transportation access, food security, exposure to violence, social support, discrimination, and access to health and social services.
What kinds of digital technologies are responsive to this announcement?
The opportunity is oriented toward digital health-based products. While the excerpt does not list specific technical requirements, the framing generally includes software and mobile applications, telehealth or remote support platforms, digital screening and referral tools, digital therapeutics, and other technology-enabled service models that can fit into real-world workflows.
Is simply tracking social determinants of health enough to be responsive?
No. The digital product is expected to do more than track social determinants of health. It should aim to measurably improve those conditions or reduce their negative impacts in ways that matter for substance use prevention, treatment engagement, harm reduction, relapse prevention, or long-term recovery.
What outcomes or use-cases does NIH appear to care about for this opportunity?
The excerpt points to use-cases such as improving prevention, treatment engagement, harm reduction, relapse prevention, and long-term recovery by reducing structural barriers and improving access to resources and supports.
What are examples of how a digital tool could address SDOH in the context of SUD?
Examples described include tools that help people navigate services, connect with community resources, coordinate care, improve communication and trust between patients and providers, reduce barriers to attending treatment, or strengthen protective social connections.
What does "R41/R42" mean in this announcement?
R41 is typically Phase I, supporting early-stage feasibility, proof-of-concept work, prototype development, and initial testing. R42 is typically Phase II, supporting more advanced research and development, refinement, and stronger evidence-building toward real-world use and market readiness.
Do applicants have to run a clinical trial?
No. The announcement is labeled "Clinical Trial Optional," meaning applicants may propose a project that includes a clinical trial, but a clinical trial is not required.
If a clinical trial is optional, what other evidence-generation approaches fit?
The excerpt indicates flexibility for approaches such as user-centered design, feasibility pilots, prototype testing, or larger effectiveness studies, depending on product maturity and the scientific questions being addressed.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with NIH SBIR requirements.
Are non-U.S. (non-domestic) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply. Non-domestic components of U.S. organizations are also not eligible.
Are any foreign activities allowed at all?
The excerpt notes that "foreign components" may be allowed as defined by the NIH Grants Policy Statement. In general NIH usage, this can mean a U.S.-based applicant includes a discrete part of the project to be performed outside the U.S. when it provides a unique resource or expertise not readily available domestically, with appropriate justification and approvals.
How is a "foreign component" different from a foreign applicant?
A foreign applicant is a non-U.S. organization applying directly, which is not allowed here. A foreign component is a portion of the work conducted outside the U.S. under a U.S.-based applicant organization, potentially allowable under NIH policy if justified and aligned with requirements.
What kinds of deployment settings does this opportunity envision?
The goal is to support scalable tools that can be deployed in communities, health systems, and support settings where people affected by substance use disorders live and seek help.
How important is commercialization in this grant?
Commercialization is central. The opportunity is aimed at small businesses building technologies with a clear path to commercialization, and competitive proposals are expected to reflect a product-development mindset alongside scientific rigor.
What does a "product-development mindset" imply for an application?
Based on the excerpt, it implies describing a clear unmet need, defining intended users and use settings, describing the digital solution concretely, and presenting a development plan that includes usability and implementation considerations plus an evidence strategy that matches the stage of the technology.
What kinds of users or customers should companies be thinking about?
The excerpt suggests thinking about adoption pathways and potential customers or purchasers such as providers, payers, public health entities, or employers, depending on the product and intended setting.
Does the excerpt provide an award ceiling or the expected number of awards?
No. The provided excerpt does not specify an award ceiling or the number of expected awards. Those details would typically be verified in the full announcement on NIH/Grants.gov or in the NIH Guide notice.
What is the CFDA number associated with this opportunity?
The excerpt associates the opportunity with CFDA number 93.279.
When was this opportunity created and what closing date is listed?
The opportunity was created on December 22, 2020, and the original closing date listed in the excerpt is February 26, 2021.
Is this a discretionary grant?
Yes. The excerpt describes it as a discretionary grant opportunity under NIH.
What is the main problem NIH is trying to solve through this opportunity?
The stated aim is to reduce substance use risk and improve outcomes by addressing social and environmental realities that drive risk and complicate recovery, recognizing that unstable living conditions, limited access to resources, and structural barriers can directly affect drug use patterns and the ability to start and sustain recovery.
Does the opportunity allow projects focused on opioids?
Yes. The excerpt explicitly notes opioid-related harms as an example within the broader focus on substance use disorders and populations affected by drug use.
Do proposed tools need to be scalable?
The stated goal is to support scalable tools deployable in real-world community and health-system settings, so scalability is a clear theme in the description.
Does the excerpt mention privacy, regulatory, or workflow considerations?
It does not provide specific requirements, but it notes that the commercialization focus implies applicants should consider regulatory and privacy considerations when applicable and how the product can integrate into real-world workflows and be sustained beyond the grant period.
Is the grant intended to fund basic science or practical product development?
The excerpt emphasizes practical, commercial-ready digital health products and translation into deployable tools, rather than focusing only on biological or clinical aspects of addiction.
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Applicants who have applied for this opportunity (RFA DA 21 031) also looked into and applied for these:
| Funding Opportunity |
|---|
| Digital Technologies to Address the Social Determinants of Health in Context of Substance Use Disorders (SUD) (R43/R44 Clinical Trial Optional) Apply for RFA DA 21 032 Funding Number: RFA DA 21 032 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Music and Health: Understanding And Developing Music Medicine (R21 Clinical Trial Optional) Apply for PAR 21 099 Funding Number: PAR 21 099 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Novel Approaches to Decrease Stigma of Substance Use Disorders in order to Facilitate Prevention, Treatment, and Support During Recovery (R41/R42 - Clinical Trials Optional) Apply for RFA DA 21 015 Funding Number: RFA DA 21 015 Agency: National Institutes of Health Category: Education, Health Funding Amount: $256,580 |
| Novel Approaches to Decrease Stigma of Substance Use Disorders in order to Facilitate Prevention, Treatment, and Support During Recovery (R43/R44 - Clinical Trials Optional) Apply for RFA DA 21 016 Funding Number: RFA DA 21 016 Agency: National Institutes of Health Category: Education, Health Funding Amount: $256,580 |
| Music and Health: Understanding And Developing Music Medicine (R01 Clinical Trial Optional) Apply for PAR 21 100 Funding Number: PAR 21 100 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Leveraging Big Data Science to Elucidate the Mechanisms of HIV Activity and Interaction with Substance Use Disorder (R21 - Clinical Trials Not Allowed) Apply for RFA DA 21 041 Funding Number: RFA DA 21 041 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Leveraging Big Data Science to Elucidate the Mechanisms of HIV Activity and Interaction with Substance Use Disorder (R01 - Clinical Trials Not Allowed) Apply for RFA DA 21 040 Funding Number: RFA DA 21 040 Agency: National Institutes of Health Category: Education, Health Funding Amount: $350,000 |
| International Research Scientist Development Award (IRSDA) (K01) Independent Clinical Trial Not Allowed Apply for PAR 21 104 Funding Number: PAR 21 104 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| International Research Scientist Development Award (IRSDA) (K01 Independent Clinical Trial Required) Apply for PAR 21 105 Funding Number: PAR 21 105 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional) Apply for RFA MH 21 145 Funding Number: RFA MH 21 145 Agency: National Institutes of Health Category: Education, Health Funding Amount: $2,000,000 |
| HEAL Initiative: Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required) Apply for RFA DA 21 030 Funding Number: RFA DA 21 030 Agency: National Institutes of Health Category: Education, Health Funding Amount: $1,750,000 |
| Pilot and Feasibility Studies in Preparation for Substance Use Prevention Trials (R34 Clinical Trial Optional) Apply for PA 21 110 Funding Number: PA 21 110 Agency: National Institutes of Health Category: Education, Health Funding Amount: $225,000 |
| Exploratory studies to investigate mechanisms of HIV infection, replication, latency, and/or pathogenesis in the context of substance use disorders (R61/R33 - Clinical Trial Not Allowed) Apply for RFA DA 22 004 Funding Number: RFA DA 22 004 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| High-throughput Discovery and Validation of Novel Signal Transducers or Small Molecules that Modulate Opioid or other Substance Use Disorder Relevant Pathways (R01 - Clinical Trials Not Allowed) Apply for RFA DA 22 006 Funding Number: RFA DA 22 006 Agency: National Institutes of Health Category: Education, Health Funding Amount: $400,000 |
| Cancer Prevention, Detection, Diagnosis, and Treatment Technologies for Global Health (U01 Clinical Trial Optional) Apply for RFA CA 21 030 Funding Number: RFA CA 21 030 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Advancing technologies to improve delivery of pharmacological, gene editing, and other cargoes for HIV and SUD mechanistic or therapeutic research (R01- Clinical Trial Optional) Apply for RFA DA 22 010 Funding Number: RFA DA 22 010 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional) Apply for PAR 21 190 Funding Number: PAR 21 190 Agency: National Institutes of Health Category: Education, Health Funding Amount: $250,000 |
| The NCI Transition Career Development Award (K22 Independent Basic Experimental Studies with Humans Required) Apply for PAR 21 318 Funding Number: PAR 21 318 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| The NCI Transition Career Development Award (K22 - Independent Clinical Trial Required) Apply for PAR 21 111 Funding Number: PAR 21 111 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| The NCI Transition Career Development Award (K22 - Independent Clinical Trial Not Allowed) Apply for PAR 21 128 Funding Number: PAR 21 128 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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